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Imported item 10
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Term of the Day

Natural history study

A natural history study is a preplanned observational study intended to track the course of a disease over time, identifying demographic, genetic, environmental and other variables that correlate with its development and outcomes in the absence of intervention, or under standard of care. Designs may be retrospective (chart review of existing records) or prospective (longitudinal follow-up of a cohort or registry).

Natural history data is particularly important in rare and paediatric diseases, where randomised placebo-controlled trials may be infeasible or unethical. The FDA (guidance on rare disease natural history studies, 2019) and the EMA accept well-designed natural history studies to define endpoints and biomarkers, identify patient subgroups, estimate sample sizes and, in some cases, serve as external or historical control arms for single-arm trials supporting orphan products.

Because they are non-interventional, natural history studies fall outside the CTR and are governed by national law (for example France's MR-003 or MR-004 reference methodologies) and by the GDPR. They typically involve secondary use of medical records, long-term follow-up, genetic data and small populations in which anonymisation is rarely achievable, so pseudonymisation, a DPIA and a robust research legal basis under Art. 9(2)(j) are essential. Registries maintained by patient organisations or academic consortia raise additional questions of joint controllership and data access governance.

C

Imported item 7

ClinicalTrials.gov is a public registry and results database maintained by the US National Library of Medicine. Sponsors and investigators submit information about clinical studies, allowing patients, researchers and the public to find study details and, where available, results. A listing is not itself regulatory approval of a study.

Key takeaways

  • ClinicalTrials.gov contains study information submitted by sponsors and investigators, who remain responsible for the information they provide and maintain.
  • FDAAA 801 reporting requirements must be fulfilled through ClinicalTrials.gov; registration elsewhere does not substitute for that specific reporting obligation.
  • ClinicalTrials.gov and the EU Clinical Trials Information System serve different functions, so multinational studies may need separate coordinated submissions.

ClinicalTrials.gov and CTIS Compared

SystemCore function
ClinicalTrials.govPublic study registration and results reporting
CTISEU/EEA trial applications, regulatory interactions and public information

The National Library of Medicine explains that not every study has the same registration duties. Determine the applicable legal, funder and publication requirements rather than assuming that every research project follows one rule. NLM’s FDAAA explanation also confirms that another registry cannot replace required ClinicalTrials.gov reporting.

EMA describes CTIS as a system supporting trial applications and oversight under the EU Clinical Trials Regulation. Operationally, assign ownership for both systems and reconcile recruitment status, study dates and public summaries.

Why It Matters for Data Protection

We recommend reviewing the public-facing record separately from internal study documents. Check contact information, free text, attachments and small-group results for unnecessary identification risks before submission. Public transparency should not become an uncontrolled release of participant records.

For example, consider a hypothetical sponsor copying an internal protocol summary into a registry. Remove internal contact lists and participant-level case details that are not appropriate for the public record, while retaining the required study information.

Frequently Asked Questions

Does registration mean the government approved the study?

No. A registry listing is not an endorsement or a substitute for required approvals.

Can CTIS replace FDAAA reporting?

No. The two systems fulfil different requirements.

Who should maintain the record?

The responsible sponsor or investigator should define ownership and keep submitted information current.

Related: CTIS; sponsor responsibilities; clinical-trial support.

Updated: 27 October 2026